Requests for a roadmap to IND are common queries at DHC. This case study combines the experiences of a range of client projects to extrapolate the elements of a typical roadmap. In this type of engagement, DHC’s cross-functional expertise provides clients with an integrated understanding of the major activities, timelines, costs and value inflection points on the path to IND. Project deliverables are valuable both for internal planning and for fundraising activities.
DHC was asked by an investor client to support due diligence on two cutting-edge CGT assets that the investor was considering combining in order to spin out a new cell therapy company. DHC reviewed quality, CMC, and regulatory information relating to both assets, performed onsite evaluations of each, evaluated manufacturing contract terms, and reviewed the new entity’s planned timelines, budgets, and milestones.
This example demonstrates that it is rarely too late to ask for a expert overview. A thorough review of the facility design documents yielded many design improvements that were possible even at this late stage, which provided significant operational improvements to benefit the facility long-term.
A pure-play gene therapy client whose product was just being spun out of academia brought DHC in early to provide long-term guidance, conceptualizing and building a dev process that would stand up to the challenges of future trial phases and into commercial production.
This case study follows the experience of a client who is new to CGT (though otherwise practiced in late stage processes) and requires CRL remediation to prepare for BLA resubmission.
Dark Horse offers varying levels of analytical support, ranging from high-level strategic oversight to detailed tactical operational support. In this case, the client required a broad scope of guidance while preparing to file for licensure.
Due to our extensive expertise in CGT, Dark Horse is uniquely positioned to identify attractive investment opportunities. Here, we performed a detailed landscape scan for a client interested in investing in the space.
Precision is key, especially in a(n international) tech transfer. DHC provided Person in Plant support in managing dose preparation training of clinical sites for this client's flagship product.
Business opportunities in CGT require gathering highly specific/technical information about current and future market expectations to both pressure-test and guide decision-making.
Clinical development of CGT products is increasingly an international endeavor, requiring an integrated global regulatory strategy.
This case study considers DHC’s proprietary quantitative modeling software, and how its adaptive approach provides clients with highly-customized probability-weighted forecasting.
Assistance with the design/use of studies demonstrating biological relevance of a lead candidate in vitro potency assay demonstrates analytical and non/preclinical core compentencies.
This study highlights a custom piece of manufacturing equipment for a cell therapy client. In addition to engineering oversight, DHC also provided regulatory and PM support.
Due diligence support for this VC client involved a rapid evaluation of CMC Phase III readiness for a cell therapy asset (complete with an element of Quality Systems).
DHC’s support for this client's gene-modified cell therapy platform demonstrated comparability of the improved manufacturing process (thus streamlining associated filings with global regulators).